QC Microbiologist

SCIOM Limited; Welwyn Garden City; On-site; GBP 30,000 - 46,000; Full time

Job summary

SCIOM Limited is seeking a Microbiologist to join our quality-focused laboratory in the United Kingdom. The role involves performing microbiological testing across finished products and raw materials, ensuring results meet specifications and regulatory standards.

You will interpret data, contribute to environmental monitoring, maintain documentation, and support method development and validation. The ideal candidate has strong GMP knowledge and meticulous attention to detail.

Qualifications

• Experience performing Microbial Limit Test and related assays.
• Familiar with cGMP and GMP documentation practices.
• Strong analytical and problem-solving skills.

Responsibilities

• Perform microbiological testing for batch release and stability.
• Interpret results and ensure compliance with procedures.
• Develop and validate microbiology methods per standards.
• Conduct environmental monitoring including settle plates.
• Review and maintain documentation and SOPs.
• Support investigations, CAPA, and QMS records.
• Write reports and participate in project activities.

Skills

Microbiology testing

Environmental monitoring

Quality systems

Change control

OOT/OOS investigations

Documentation review

Job description

The primary responsibilities of a Microbiologist include sample analysis and reporting for analysis, finished products, validation, stability, equipment Qualification, Calibration, and documentation review for Microbiology. This must be executed in accordance with cGMP guidelines.

• Perform microbiological testing of microbial limit test of batch release and stability as per the approved SOP and STP.
• Interpretation and release of the analysed microbiology testing observe the structural characteristics of the microorganisms to identify the gram nature, family and species of the microorganisms.
• Analysing samples by performing Microbial Limit Test, Bacterial Endotoxin Test, Preservative Efficacy Test for finished & stability products, and raw material, as per the approved procedures and analysis with appropriate documentation and strict adherence to Good Documentation Practices.
• To perform the Environmental Monitoring by Settle Plate and another different method as per the approved procedures and analysis with appropriate documentation and strict adherence to Good Documentation Practices.
• To develop and validate Microbiology methods for the testing of manufactured products to agreed specifications that remains in compliance with current relevant pharmacopeial standards and requirements.
• To perform Growth Promotion Test as per the approved SOP and along with the documentation for the same.
• Provide microbiological expertise during investigations, root cause analysis, change controls, and deviations.
• Initiation and Review of Change control, deviation, complaints and any QMS records and responsible for closing the QMS actions.
• To perform trend analysis of microbiology tests results and investigate any OOT/OOS analytical according to the relevant SOPs.
• To maintain the stock of the microbiological consumables as per the requirements.
• To maintain and clean the microbiology laboratory as per the approved SOP.
• Perform the Qualification, Calibration, maintenance and Validation for all laboratory instruments.
• Participate in documentation, laboratory systems and processes to include updating existing ones as required.
• To write reports, SOPs and other documentation when required.
• The role will include a mixture of routine and project activities, including the implementation of a new laboratory system.